News & Events zu Celcuity Inc. (CELC)CELCCelcuity Inc.

Celcuity Updates Clinical Results for Gedatolisib

Celcuity announced updated clinical results from the Phase 1b/2 study evaluating gedatolisib in patients with metastatic castration-resistant prostate cancer, or mCRPC. These data were presented at the European Society of Medical Oncology, or ESMO, Congress on Friday, October 23, 2026, at 9:15 a.m. EDT/3:15 p.m. CEST at a poster presentation: In this Phase 1b/2 study, 45 patients with mCRPC were randomly assigned to receive 600 mg darolutamide twice daily combined with either 120 mg gedatolisib in Arm 1, 180 mg gedatolisib in Arm 2 and 240 mg gedatolisib in Arm 3. In all arms, gedatolisib was administered intravenously on days 1, 8, and 15 of a 28-day cycle, then two weeks off. Additionally, all patients received prophylactic treatment for stomatitis. Baseline characteristics were generally consistent across dose cohorts; over 50% had bone disease, 33% had phosphatase and tensin hemolog loss. Data was analyzed as of an August 14 cut-off date. Median rPFS was 15.7 months with an rPFS6 rate of 82.2% in patients with prior abiraterone exposure. Median rPFS was 9.1 months with an rPFS6 rate of 62.5% in patients with prior enzalutamide exposure. PSA greater than or equal to 50% decreases from baseline were observed across all dose levels; response rates were 36%, 47% and 67% at the 120-, 180-, and 240-mg gedatolisib dose levels, respectively, in patients with prior exposure to either abiraterone or enzalutamide. Exploratory analyses of patients according to their PTEN status suggest activity is independent of PTEN status. Gedatolisib plus darolutamide demonstrated a manageable safety profile across the evaluated dose levels with one dose limiting toxicity, no Grade 4/5 treatment related adverse events, and no TRAEs leading to treatment discontinuation or death. Grade 3 TRAEs occurred in 9 patients with only rash and pruritus occurring in more than one patient. The randomized Phase 2 study is expected to evaluate two different groups of patients with the objective of determining the recommended phase 3 dose level. Subjects in Group 1 will be those who received prior abiraterone for either hormone sensitive or castration resistant prostate cancer. Subjects in Group 2 will be those who received prior enzalutamide or apalutamide for either hormone sensitive or castration resistant prostate cancer. Celcuity anticipates initiating this study in the first half of 2027 after completion of the Phase 1b part of the study.

Celcuity Appoints David Gryska to Board of Directors

Celcuity (CELC) announced the appointment of David Gryska to its Board of Directors. Throughout the past 25 years, Gryska has served on the Boards of eight public biotechnology companies and currently serves on the Board of Directors of Definium Therapeutics (DFTX)

Celcuity's REVTORPYK Now Available in the U.S.

Celcuity announced that REVTORPYK is now commercially available in the United States for eligible patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. REVTORPYK was approved in combination with palbociclib and fulvestrant and in combination with fulvestrant, by the U.S. Food and Drug Administration on July 14, 2026. "Our experienced commercial and medical affairs teams have been laying the groundwork for a successful launch with healthcare providers, payers, and patient advocacy partners since REVTORPYK was approved," said Brian Sullivan, CEO and co-founder of Celcuity. "Now that REVTORPYK is commercially available, we are focused on working with physicians to bring this new treatment option to patients living with HR+/HER2- advanced breast cancer."